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Fraunhofer (News - Alert) USA Center for Molecular Biotechnology (FhCMB) announced
today that clearance was obtained from the U.S. Food and Drug
Administration (FDA) for an investigational new drug (IND), Fraunhofer's
plant-derived malaria transmission-blocking vaccine (TBV), which targets
the Pfs25 antigen, to proceed into the clinic in a Phase 1 safety
and immunogenicity study.

Antibodies directed at Pfs25 can block transmission of the
malaria parasite from mosquitoes to humans by preventing the parasite
from developing in the mosquito. In preclinical models, purified
plant-derived virus-like particles containing Pfs25, in
combination with the adjuvant Alhydrogel®, have been shown to induce
antibodies that effectively block infection of mosquitoes that have fed
on an infectious blood meal. If these results can be reproduced in
humans, the vaccine approach may provide a strategy to interrupt malaria
transmission and thereby contribute to reduction of the P. falciparum
disease buden.

"Entering this clinical trial is an important milestone," said Dr.
Yusibov, Executive Director of FhCMB. "We have moved targets from
molecular engineering all the way through to pilot scale manufacturing
in plants under good manufacturing practices and evaluation in a Phase 1
clinical trial."

Development of this malaria TBV is an effort to improve global health by
supporting the development of critical platform technologies for
delivering vaccines to malaria-endemic countries. As part of the planned
collaboration strategy, FhCMB, the PATH Malaria Vaccine Initiative (MVI)
and Accelovance entered into an agreement to conduct a Phase 1 clinical
trial.

"We are excited to see this promising new vaccine approach advance to
clinical testing," says Ashley J. Birkett, PhD, Director of MVI.
"Vaccines that can induce immunity to break the cycle malaria parasite
transmission between humans and mosquitoes have the potential important
interventions to accelerate future elimination and eradication efforts."

This Phase 1 clinical trial was initiated in early November and is being
conducted by Accelovance.

About Fraunhofer

Fraunhofer USA is a subsidiary of Fraunhofer-Gesellschaft, a world
leading applied R&D organization with 66 institutes and independent
research units throughout Germany. Fraunhofer USA's nine centers perform
applied research under contract to government and industry.

Fraunhofer USA Center for Molecular Biotechnology is developing a safe,
rapid and economical alternative for vaccine production. The Center
conducts research in the area of plant biotechnology, utilizing new,
cutting edge approaches to assist the diagnosis, prevention and
treatment of human and animal diseases. With its GMP production
facility, the Center provides the full complement of capabilities from
target expression through Phase 1 and 2 clinical product development.